12 Things You Should Know About the New “Female Viagra”

The “little pink pill” called Addyi (pronounced “ADD-ee”—aka “female Viagra”) has been approved by the FDA—five long and contested years after it was first submitted. It’s the first US prescription medication for female low-sex drive. If you’re a woman and low libido is taking a toll on your intimate relationship, you’re likely intrigued by a new drug designed to boost desire and improve your sex life.

“Addyi” is kind of a cuddly name, but we think there are a few things you should know about this new drug, whose generic chemical name is flibanserin, before you ask your doctor for a prescription. We’ll let you know about the slick media campaign sponsored in part by the drug’s manufacturer that put enormous political pressure on the FDA to approve a drug that it had previously been very wary of approving. In short, Addyi is hugely controversial and comes with many caveats and warnings…not to mention heated debate among mental health and sexual-health professionals—and women.

Here’s what you need to know…

1. It’s not really “female Viagra.”That drug (and similar ones) works on performance, specifically increasing blood flow to the penis in men who are already aroused. Flibanserin is supposed to act on the step before that—the desire stage. It was originally developed as an antidepressant, and while it didn’t work well for boosting mood, researchers noticed an influence on sex drive. Likely mechanism—promoting the release of dopamine, a “feel good” chemical in the brain.

2. It’s only for low libido that causes distress. The mental health condition called “female sexual interest/arousal disorder” (formerly “hypoactive sexual desire disorder”) is marked by an ongoing lack of fantasies and desire for sexual activity that causes you distress or severely strains your relationship with your partner…and isn’t caused by another disorder, another medication or a relationship problem. In short, low libido itself isn’t a disorder. If your sex drive, or lack thereof, isn’t causing you distress, you don’t need Addyi.

3. Not everyone thinks this disorder is…real. No one’s contesting that some women experience distressing low libido, but some clinicians say female sexual desire is often over-medicalized—and that it’s doubtful that low desire can be effectively treated with a drug. There’s debate about this in the medical and psychological health communities. (See Can Life Without Sex Be Happy?)

4. It’s not very effective. Women on the drug report small improvements in libido at best. Only about 8% to 13% of women said they were “much improved” or better in terms of desire or sexually satisfying events. Supporters of the drug argue that these improvements, while seemingly small, are meaningful to the women who have them.

5. It has to be taken every day. Unlike Viagra, Addyi is not an “on-demand,” fast-acting aid to sex. It’s a pill that you take every day, so you have to commit to it—and its side effects—for months, if not years.

6. It’s expensive. The price hasn’t been announced, but when it becomes available in mid-October, Addyi is expected to be about as expensive on a monthly basis as Viagra, which can cost as much as $400 for 10 pills—typically, a month’s supply.

7. It was rejected twice before. The FDA voted against approving flibanserin in 2009 because it wasn’t effective enough. In 2013, new trials found it to be effective based on a different parameter, but it was rejected again. This time the agency cited safety concerns, including a risk for low blood pressure, fainting and drowsiness. Research shows that 28.6% of those taking the drug experienced “adverse events” related to sedation or low blood pressure, versus 9.4% of those taking a placebo. The drug can also cause nausea, which, while not a safety issue, isn’t exactly an aphrodisiac either.

8. Side effects are still a concern. Those side effects are still there, but now it’s recommended to be taken only at night, so drowsiness is less of an issue. New data did reassure the FDA panel that women who took the pill at night were OK to drive the next day. How that works if you’re, say, a shift worker who needs to drive at night isn’t clear.

9. You can’t drink alcohol if you take it. Alcohol makes side effects such as drowsiness and low blood pressure worse. Critics argue that it’s unreasonable to expect women who do drink alcohol to stop entirely for the duration of the time they take this drug…and the combination can be dangerous. We’ll know how bad the alcohol/Addyi combo is only after women start combining the two in the real world, however. Why? The only study about how alcohol interacts with flibanserin presented to the FDA had just 25 subjects…and 23 of them were men! Many other medications also interact with flibanserin and can make its side effects worse—anxiety medications, sleep aids, oral contraceptives, drugs for yeast infections and more.

10. The FDA was under extraordinary public pressure to approve the drug. After the unfavorable 2013 ruling, an advocacy group called Even the Score was formed to campaign for “gender equality” in treatments for sexual dysfunction. The group—which gets funding from Sprout Pharmaceuticals, the makers of Addyi—claims there are 26 sexual dysfunction drugs for men and none for women. In reality, there are zero low-sexual-desire drugs for men (again, there’s a difference between a libido drug and a performance drug). Even the Score has been accused of unfairly politicizing the FDA’s rulings on flibanserin.

11. It wasn’t a unanimous decision. When the FDA advisory committee voted to recommend approving the drug in June, 18 members voted yay, but six voted nay. That shows there are still significant questions about the medication’s risks versus its benefits.

12. It’s approved only for premenopausal women. That’s the only group for whom the FDA has approved this drug. Sprout is now doing studies on postmenopausal women…and may study men in the future, too. But it’s not approved for those groups, and it isn’t known whether it will work or be safe for them.

FIGURING OUT WHAT’S RIGHT FOR YOU

If you do decide to get a prescription, you and your doctor will need to be aware of the many contraindications of this new drug…and that you’re sure you’re fine with a no-alcohol lifestyle.

If you’re postmenopausal and considering trying to get flibanserin as an off-label medication, you may be better off with another medicine that has been shown to help women with low libido—low-dose testosterone. It’s not approved by the FDA for this purpose, but many ob/gyns prescribe it to older women for this issue.

Source: Source: Article titled “Evaluation of Flibanserin: Science and Advocacy at the FDA,” by researchers at University of Pittsburgh, Medical College of Wisconsin, Milwaukee, and Johns Hopkins Bloomberg School of Public Health, Baltimore, published in Journal of the American Medical Association.
Date: August 20, 2015
Publication: Bottom Line Health

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12 Things You Should Know About the New “Female Viagra”

The “little pink pill” called Addyi (pronounced “ADD-ee”—aka “female Viagra”) has been approved by the FDA—five long and contested years after it was first submitted. It’s the first US prescription medication for female low-sex drive. If you’re a woman and low libido is taking a toll on your intimate relationship, you’re likely intrigued by a new drug designed to boost desire and improve your sex life.

“Addyi” is kind of a cuddly name, but we think there are a few things you should know about this new drug, whose generic chemical name is flibanserin, before you ask your doctor for a prescription. We’ll let you know about the slick media campaign sponsored in part by the drug’s manufacturer that put enormous political pressure on the FDA to approve a drug that it had previously been very wary of approving. In short, Addyi is hugely controversial and comes with many caveats and warnings…not to mention heated debate among mental health and sexual-health professionals—and women.

Here’s what you need to know…

1. It’s not really “female Viagra.”That drug (and similar ones) works on performance, specifically increasing blood flow to the penis in men who are already aroused. Flibanserin is supposed to act on the step before that—the desire stage. It was originally developed as an antidepressant, and while it didn’t work well for boosting mood, researchers noticed an influence on sex drive. Likely mechanism—promoting the release of dopamine, a “feel good” chemical in the brain.

2. It’s only for low libido that causes distress. The mental health condition called “female sexual interest/arousal disorder” (formerly “hypoactive sexual desire disorder”) is marked by an ongoing lack of fantasies and desire for sexual activity that causes you distress or severely strains your relationship with your partner…and isn’t caused by another disorder, another medication or a relationship problem. In short, low libido itself isn’t a disorder. If your sex drive, or lack thereof, isn’t causing you distress, you don’t need Addyi.

3. Not everyone thinks this disorder is…real. No one’s contesting that some women experience distressing low libido, but some clinicians say female sexual desire is often over-medicalized—and that it’s doubtful that low desire can be effectively treated with a drug. There’s debate about this in the medical and psychological health communities. (See Can Life Without Sex Be Happy?)

4. It’s not very effective. Women on the drug report small improvements in libido at best. Only about 8% to 13% of women said they were “much improved” or better in terms of desire or sexually satisfying events. Supporters of the drug argue that these improvements, while seemingly small, are meaningful to the women who have them.

5. It has to be taken every day. Unlike Viagra, Addyi is not an “on-demand,” fast-acting aid to sex. It’s a pill that you take every day, so you have to commit to it—and its side effects—for months, if not years.

6. It’s expensive. The price hasn’t been announced, but when it becomes available in mid-October, Addyi is expected to be about as expensive on a monthly basis as Viagra, which can cost as much as $400 for 10 pills—typically, a month’s supply.

7. It was rejected twice before. The FDA voted against approving flibanserin in 2009 because it wasn’t effective enough. In 2013, new trials found it to be effective based on a different parameter, but it was rejected again. This time the agency cited safety concerns, including a risk for low blood pressure, fainting and drowsiness. Research shows that 28.6% of those taking the drug experienced “adverse events” related to sedation or low blood pressure, versus 9.4% of those taking a placebo. The drug can also cause nausea, which, while not a safety issue, isn’t exactly an aphrodisiac either.

8. Side effects are still a concern. Those side effects are still there, but now it’s recommended to be taken only at night, so drowsiness is less of an issue. New data did reassure the FDA panel that women who took the pill at night were OK to drive the next day. How that works if you’re, say, a shift worker who needs to drive at night isn’t clear.

9. You can’t drink alcohol if you take it. Alcohol makes side effects such as drowsiness and low blood pressure worse. Critics argue that it’s unreasonable to expect women who do drink alcohol to stop entirely for the duration of the time they take this drug…and the combination can be dangerous. We’ll know how bad the alcohol/Addyi combo is only after women start combining the two in the real world, however. Why? The only study about how alcohol interacts with flibanserin presented to the FDA had just 25 subjects…and 23 of them were men! Many other medications also interact with flibanserin and can make its side effects worse—anxiety medications, sleep aids, oral contraceptives, drugs for yeast infections and more.

10. The FDA was under extraordinary public pressure to approve the drug. After the unfavorable 2013 ruling, an advocacy group called Even the Score was formed to campaign for “gender equality” in treatments for sexual dysfunction. The group—which gets funding from Sprout Pharmaceuticals, the makers of Addyi—claims there are 26 sexual dysfunction drugs for men and none for women. In reality, there are zero low-sexual-desire drugs for men (again, there’s a difference between a libido drug and a performance drug). Even the Score has been accused of unfairly politicizing the FDA’s rulings on flibanserin.

11. It wasn’t a unanimous decision. When the FDA advisory committee voted to recommend approving the drug in June, 18 members voted yay, but six voted nay. That shows there are still significant questions about the medication’s risks versus its benefits.

12. It’s approved only for premenopausal women. That’s the only group for whom the FDA has approved this drug. Sprout is now doing studies on postmenopausal women…and may study men in the future, too. But it’s not approved for those groups, and it isn’t known whether it will work or be safe for them.

FIGURING OUT WHAT’S RIGHT FOR YOU

If you do decide to get a prescription, you and your doctor will need to be aware of the many contraindications of this new drug…and that you’re sure you’re fine with a no-alcohol lifestyle.

If you’re postmenopausal and considering trying to get flibanserin as an off-label medication, you may be better off with another medicine that has been shown to help women with low libido—low-dose testosterone. It’s not approved by the FDA for this purpose, but many ob/gyns prescribe it to older women for this issue.

Source: Source: Article titled “Evaluation of Flibanserin: Science and Advocacy at the FDA,” by researchers at University of Pittsburgh, Medical College of Wisconsin, Milwaukee, and Johns Hopkins Bloomberg School of Public Health, Baltimore, published in Journal of the American Medical Association.
Date: August 20, 2015
Publication: Bottom Line Health